Mobile Health Application to Improve Patient Satisfaction After Urethroplasty

November 22, 2024 updated by: Ziho Lee, Northwestern University

Evaluation of a Mobile Health Application to Improve Patient Satisfaction and Outcomes After Urethroplasty: a Prospective Randomized Controlled Trial

Create a custom urethroplasty mobile application that will guide patients through through the surgical process.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age or older
  • Have a Urethral stricture and are under going urethroplasty surgery

Exclusion Criteria:

  • Patients that do not have mobile phone capabilities
  • Patients who have physical or cognitive impairment when using a mobile phone or answering questionnaires
  • Inability to provide consent to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard of Care
Standard Care
Other: Standard of Care
Office Based Pathway
Other: Standard Care + GetWell App
Other: Standard of Care
Office Based Pathway
Other: GetWell Mobile Application
GetWell utilizes an interactive health care application to allow patients to participate in their care. We plan to work with GetWell to develop a custom built plan for urethroplasty patients and provide patient education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improve patient satisfaction, education and reported outcomes
Time Frame: 0 to 3 months
Asses through Patient reported outcome measurement survey, Urethral Stricture Symptom and Impact Measurement and Patient-Reported Outcomes Measurement information System 29-item profile (PROMIS) which assesses pain intensity using a 0-10 rating item, with higher scores being a worse outcome.
0 to 3 months
Change in rate of patient phone calls and messages
Time Frame: 0 to 12 months
assess through chart review to evaluate the number of chart messages and phone calls
0 to 12 months
Rate of emergency department visits
Time Frame: 0 to 12 months
Assess through chart review and patient reporting events.
0 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 28, 2023

Primary Completion (Actual)

September 11, 2024

Study Completion (Actual)

September 11, 2024

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00219774

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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